510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K111059Substantially Equivalent

Gyrus Acmil Bipolarlaproscopic Loop (Pks Bill)

Gyrus ACMI, Inc., Southborough MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111059 is the FDA 510(k) clearance record for GYRUS ACMIL BIPOLARLAPROSCOPIC LOOP (PKS BILL), a class II device, cleared for Gyrus Acmi, Inc. on under FDA product code HIN (Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)). FDA records list 67 510(k) clearances for Gyrus Acmi, Inc., from to . As of , FDA records show no recalls naming K111059.

Clearance record

Decision date
Received
(136 days to decision)
Product code
HIN Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
Regulation
21 CFR 884.4150
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Gyrus Acmi, Inc. 136 Tpke. Rd., Southborough MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HIN

Trailing 12 months

FDA records hold no clearances under product code HIN in the trailing twelve months.

FDA records show no clearances under product code HIN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HIN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260